Protocol/serial number

Study information

Scientific title

Acronym

NEST Study

Study hypothesis

Does cooling neonates requiring extra-corporeal membrane oxygenation (ECMO) to 34°C for the first 48 to 72 hours of their ECMO run result in improved neurodevelopmental outcome at 2 years corrected age?

Please note that as of 11/02/2009 this record was updated to include amended trial dates. The initial trial dates at the time of registration were: Initial anticipated start date: 01/11/2005 Initial anticipated end date: 30/11/2010

Please note that as of 19/05/10 this record was updated. All updates can be found in the relevant field with the above update date.

Ethics approval

Added 11/02/2009: Trent Multi-Centre Research Ethics Committee gave approval on the 9th June 2005 (ref: 05/MRE04/22)

Condition

Fully grown newborn babies requiring help with their breathing and circulation.

Intervention

Babies receiving ECMO will be randomised to standard ECMO or ECMO with mild cooling.

As of 19/05/10 this trial is now in follow-up phase.

As of 11/07/2012 the recruitment and follow-up phases are complete and the data collected are under analysis.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Current information as of 19/05/10:Cognitive score from the Bayley scales of Infant and toddler Development, 3rd edition (Bayley-III) at age of 2 years (24 - 27 months)

Initial information at time of registration:The Mental Development Index (MDI) of the Bayley scales of the surviving children in each arm of the study at the age of 2 years (24 - 27 months)

Secondary outcome measures

Current information as of 19/05/10: 1. Death 2. Neurological optimality score 3. Gross and fine motor score from the Bayley-III 4. Cerebral Palsy 5. Gross motor function classification score (GMFCS) 6. Seizures requiring regular anticonvulsant treatment 7. Visual difficulties not corrected by spectacles 8. Hearing difficulties requiring aids 9. Language: expressive and receptive scores from the Bayley-III 10. Parent Report of Children's Abilities (PARCA-R) 11. Infant Characteristics Questionnaire 12. The Brief Infant-Toddler Social and Emotional Assessment (BITSEA) 13. Measure of growth: height, weight and head circumference A child will be considered to be functioning within the normal range for age if their results are within the normal range for all Bayley scores and they have a normal neurological examination, normal vision (including with spectacles) and normal hearing (no aids).

Initial information at time of registration:1. A structured neurological assessment2. Parent perception of their childs health at two years of age3. The Psychomotor Development Index (PDI) from the Bayley scales4. Visuospatial assessment5. The Testers rating of child behaviour

Overall trial start date

03/10/2005

Overall trial end date

31/05/2012

Reason abandoned

Eligibility

Participant inclusion criteria

Babies recruited to the study must be the existing standard criteria for ECMO eligibility.These include:1. To be at least 35 weeks gestation2. To be at least 2000 g birth weight3. To have no uncontrolled bleeding disorder4. To have no congenital or acquired central nervous system (CNS) disorder5. To have undergone no more than 7 consecutive days of high pressure ventilation prior to referral for ECMO6. To be suffering from a condition which is potentially reversible7. To have evidence of severe cardio respiratory failure8. Less than 29 days of age, either sex

Participant type

Patient

Age group

Neonate

Gender

Both

Target number of participants

118

Participant exclusion criteria

1. All neonates referred with diaphragmatic hernia2. All neonates receiving ECMO for post operative cardiac support